US20140263322A1 - Coring-free valve system - Google Patents

Coring-free valve system Download PDF

Info

Publication number
US20140263322A1
US20140263322A1 US13/802,935 US201313802935A US2014263322A1 US 20140263322 A1 US20140263322 A1 US 20140263322A1 US 201313802935 A US201313802935 A US 201313802935A US 2014263322 A1 US2014263322 A1 US 2014263322A1
Authority
US
United States
Prior art keywords
septum
needle
accordance
expansion portion
valve system
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US13/802,935
Inventor
Salah Ghodbane
Gary Eugene Dawson
Kimberly Ann Moos
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mallinckrodt LLC
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to US13/802,935 priority Critical patent/US20140263322A1/en
Priority to PCT/US2014/020582 priority patent/WO2014158859A1/en
Assigned to MALLINCKRODT LLC reassignment MALLINCKRODT LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DAWSON, GARY E., MOOS, KIMBERLY A., GHODBANE, SALAH
Assigned to DEUTSCHE BANK AG NEW YORK BRANCH reassignment DEUTSCHE BANK AG NEW YORK BRANCH SECURITY INTEREST Assignors: CNS THERAPEUTICS, INC., ENTERPRISES HOLDINGS, INC., IMC EXPLORATION COMPANY, LAFAYETTE PHARMACEUTICALS LLC, LIEBEL-FLARSHEIM COMPANY LLC, LUDLOW CORPORATION, MALLINCKRODT BRAND PHARMACEUTICALS, INC, MALLINCKRODT CARIBBEAN, INC., MALLINCKRODT CB LLC, MALLINCKRODT ENTERPRISES HOLDINGS, INC., MALLINCKRODT ENTERPRISES LLC, MALLINCKRODT FINANCE GMBH, MALLINCKRODT INC., MALLINCKRODT INTERNATIONAL FINANCE S.A., MALLINCKRODT LLC, MALLINCKRODT US HOLDINGS INC., MALLINCKRODT US HOLDINGS LLC, MALLINCKRODT US POOL LLC, MALLINCKRODT VETERINARY, INC., MEH, INC
Publication of US20140263322A1 publication Critical patent/US20140263322A1/en
Assigned to STRATATECH CORPORATION, MALLINCKRODT CARRIBEAN, INC., INFACARE PHARMACEUTICAL CORPORATION, THERAKOS, INC., MALLINCKRODT US POOL LLC, MALLINCKRODT INTERNATIONAL FINANCE S.A., MALLINCKRODT US HOLDINGS LLC, LAFAYETTE PHARMACEUTICALS LLC, MALLINCKRODT ENTERPRISES LLC, MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED, MALLINCKRODT FINANCE GMBH, MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING D.A.C.), INO THERAPEUTICS LLC, CNS THERAPEUTICS, INC., IKARIA THERAPEUTICS LLC, SUCAMPO PHARMA AMERICAS LLC, MEH, INC., MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED), IMC EXPLORATION COMPANY, LIEBEL-FLARSHEIM COMPANY LLC, MALLINCKRODT LLC, MALLINCKRODT US HOLDINGS LLC (F/K/A MALLINCKRODT US HOLDINGS INC.), VTESSE LLC (F/K/A VTESSE INC.), ST SHARED SERVICES LLC, MALLINCKRODT VETERINARY, INC., MALLINCKRODT BRAND PHARMACEUTICALS LLC (F/K/A MALLINCKRODT BRAND PHARMACEUTICALS, INC.), LUDLOW LLC (F/K/A LUDLOW CORPORATION), SpecGx LLC, OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.), MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED), MALLINCKRODT CB LLC, MNK 2011 LLC (F/K/A MALLINCKRODT INC.), MALLINCKRODT ENTERPRISES HOLDINGS LLC (F/K/A MALLINCKRODT ENTERPRISES HOLDINGS, INC.) reassignment STRATATECH CORPORATION RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001 Assignors: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Abandoned legal-status Critical Current

Links

Images

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/002Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/04Access sites having pierceable self-sealing members
    • A61M39/045Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/26Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0036Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
    • A61M2039/0081Means for facilitating introduction of a needle in the septum, e.g. guides, special construction of septum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1072Tube connectors; Tube couplings with a septum present in the connector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/24Check- or non-return valves
    • A61M2039/242Check- or non-return valves designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/24Check- or non-return valves
    • A61M2039/2433Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc

Definitions

  • the field relates generally to fluid valve systems, and more particularly to fluid valve systems having septa or a septum for receiving a needle.
  • Many conventional valve systems for sealing a container include a septum designed to be pierced by a needle or cannula of a syringe. Fluid may be transferred through the needle from the container to the syringe or vice versa.
  • Conventional needles often have holes at or near the tip of the needle. Holes through the septum formed by the needle may have an undesirable coring effect on the septum in which the needle undesirably removes a piece of the septum and creates particulates. These particulates may clog the needle or tube and obstruct the flow path of the fluid, or be released into the flow path and possibly into the patient. The particulates may further contaminate any fluid flowing through the flow path.
  • Some septa have a pre-formed slit designed to receive the needle, but the needle may pierce the septum anywhere the tip makes contact, and may not necessarily be inserted through the slit area.
  • a valve system for receiving a needle comprises a housing defining at least a portion of a fluid flow channel.
  • the housing includes a first end, a second end, and a receiving portion.
  • a septum is mounted in the housing for sealing the first end of the housing.
  • the septum includes a longitudinal axis and is formed from a resilient material.
  • the septum also includes a head portion including a tapered opening configured to receive the needle, a sealing portion configured to create a seal around the needle, and an expansion portion extending from the head portion opposite the tapered opening.
  • the expansion portion includes a chamber having a closed end, at least one relief channel, and apertures formed in the relief channel. The apertures facilitate fluid communication between the chamber and the receiving portion when the expansion portion is extended parallel to the longitudinal axis into the receiving portion in an open position. The apertures are also configured to prevent flow communication when the expansion portion is in a closed position.
  • a septum in another aspect, comprises a head portion including a tapered opening configured to receive a needle about a longitudinal axis, a sealing portion configured to create a seal about a needle, and an expansion portion extending from the head portion opposite the tapered opening.
  • the expansion portion includes a chamber having a closed end housed within the expansion portion, at least one relief channel, and a plurality of apertures formed in the relief channel. The apertures facilitate flow communication through the expansion portion when the expansion portion is extended parallel to the longitudinal axis in an open position. The apertures also prevent flow communication when the expansion portion is in a closed position.
  • FIG. 1 is an exploded perspective view of a valve system including a cap, a septum, and a housing of one embodiment
  • FIG. 2A and FIG. 2B respectively show perspective and side views of the septum of FIG. 1 in a closed position
  • FIG. 3A and FIG. 3B respectively show perspective and side views of the septum of FIG. 1 in an intermediate position
  • FIG. 4A and FIG. 4B respectively show perspective and side views of the septum of FIG. 1 in an open position
  • FIG. 5 is a cross-section view of the valve system of FIG. 1 with the septum in a closed position;
  • FIG. 6 is a cross-section view of the valve system of FIG. 1 with the septum in an intermediate position
  • FIG. 7 is a cross-section view of the valve system of FIG. 1 with the septum in an open position
  • a system generally designated 100 is for use with a medical device of a fluid delivery system.
  • system 100 may be used with other devices without departing from the scope of this disclosure.
  • system 100 is configured to prevent coring of an expanding member, such as a septum 102 , when a needle (not shown in FIG. 1 ) is inserted therein, while maintaining a fluid flow channel (not shown in FIG. 1 ) therethrough.
  • System 100 includes a cap 106 having a tapered opening 122 for receiving the needle, a housing 104 having a first end 108 for receiving cap 106 , a receiving chamber 114 for receiving septum 102 that controls fluid flow through system 100 , and a second end 110 to facilitate directing fluid between system 100 and a medical device.
  • Housing 104 , septum 102 , and cap 106 are configured to be coaxially aligned along longitudinal centerline axis 101 .
  • the fluid is in liquid form and passes through a centrally formed fluid flow channel as described in further detail below.
  • valve system 100 may be connected to a medical valve connector, such as a Luer connector.
  • system 100 may be used to transfer a fluid between any two devices. For example, for transferring fluid between a needle or cannula and a vial, for use in a pumping system for filling or emptying a vial or tube, or for transferring fluid between a needle and an IV line.
  • a conventional needle such as a bevel-tipped needle may be used, or a blunt-tipped cannula including a side port.
  • any needle or cannula may be used with system 100 .
  • septum 102 is mounted within housing 104 of system 100 for sealing housing first end 108 and is substantially secured within housing 104 by cap 106 .
  • system 100 is designed as a two-way fluid connector valve for flow of fluid between two medical devices, it is to be understood that the direction of fluid flow as well as the particular details, size and shape of system 100 and its components may vary, including providing for one-way fluid flow, if desired.
  • cap 106 is configured to be coupled to first end 108 of housing 104 .
  • cap 106 is coupled to housing 104 via a press-fit connection.
  • cap 106 may be coupled to first end 108 of housing 104 by any connection means that allows for system 100 to function as described herein, such as threadably coupled, snap-fit, or permanently attached.
  • Cap 106 includes a first end 119 and an opposing second end 121 .
  • Cap first end 119 includes conically-tapered opening 122 that narrows within cap 106 and is defined by an annular guiding surface 120 .
  • Guiding surface 120 extends into cap 106 such that opening 122 terminates between first end 119 and second end 121 .
  • Guiding surface 120 is configured to direct the needle through taped opening 122 .
  • Cap 106 is formed of a hard, durable material such that contact with the needle does not damage cap 106 .
  • septum 102 includes two adjacent elements or portions.
  • septum 102 includes a head portion 124 and an expansion portion 128 .
  • a first end 123 of head portion 124 includes a second tapered opening 136 configured to receive a needle and expansion portion 128 includes a chamber (not shown in FIG. 1 ) defined therein and a relief channel 126 .
  • Expansion portion 128 extends from a head portion second end 125 opposite tapered opening 136 .
  • a sealing portion (not shown in FIG. 1 ) is defined within septum 102 between tapered opening 136 and the chamber. The sealing portion is configured to create a seal about the needle.
  • the chamber is configured to receive the needle such that a pushing force by the needle facilitates to elongate expansion portion 128 along axis 101 as described in further detail below.
  • Housing 104 includes first end 108 and opposing second and 110 .
  • First end 108 is configured to accept cap 106 on an outer surface 109 and is further configured to receive septum 102 within receiving chamber 114 within first end 108 .
  • Second end 110 includes a fluid flow member 118 and a connector portion (not shown in FIG. 1 ) for connecting system 100 to a medical device, such as a Luer device.
  • the connector portion may be threaded for ease of connection to the device. It is to be noted that any type of medical device may be connected to the connector portion of the second end 110 .
  • system 100 will be described with respect to the needle of a syringe being inserted into opening 122 and a Luer device being connected to the connector portion of the second end 110 , where the Luer device is in communication with a fluid delivery system, such as an I.V. set.
  • a fluid delivery system such as an I.V. set.
  • the Luer device and I.V. set are omitted from the drawings for brevity.
  • FIGS. 2A , 3 A, and 4 A illustrate a cross-sectional perspective view of septum 102 in the closed position, intermediate position, and open position, respectively.
  • FIGS. 2B , 3 B, and 4 B show a perspective side view of septum 102 in the closed position, intermediate position, and open position, respectively.
  • Septum 102 is made of a single piece of a substantially resilient material, such as rubber, latex, or silicone. Alternatively, septum 102 may be formed of any resilient material that enables system 100 to function as described herein.
  • septum 102 includes head portion 124 and expansion portion 128 . Head portion 124 includes first end 123 and opposing second end 125 .
  • expansion portion 128 extends from head portion second end 125 opposite sealing portion 132 and opening 136 .
  • Expansion portion 128 includes a chamber 130 defined therein. Chamber 130 extends within expansion portion 128 between sealing portion 132 and a closed end 134 of chamber 130 .
  • Septum 102 is configured such that opening 136 , sealing portion 132 , and chamber 130 are co-axial about centerline 101 and form a single-ended tunnel between head portion first end 123 and chamber closed end 134 .
  • Expansion portion 128 further includes a relief channel 126 formed in an outer wall 127 of expansion portion 128 and has a depth of approximately half the thickness of outer wall 127 .
  • relief channel 126 may be of any depth that facilitates septum 102 to function as described herein.
  • relief channel 126 is a continuously-spiraled channel defined between head portion second end 125 and a distal tip of expansion portion 128 .
  • Relief channel 126 terminates with a complete circular cut about the base of extension portion 128 at the union of expansion portion 128 and head portion second end 125 .
  • relief channel 126 may be a plurality or series of individual channels formed in outer wall 127 .
  • FIGS. 2A and 2B show septum 102 in the relaxed, or closed, position, wherein expansion portion 128 is at rest and has a first length L 1 .
  • relief channel 126 is closed and appears as a spiraled line about expansion portion 128 .
  • FIGS. 3A and 3B show septum 102 in an intermediate position, wherein expansion portion 128 is at least partially expanded. In the intermediate position, expansion portion 128 has a second length L 2 , which is greater than first length L 1 .
  • extension portion 128 is extended in a longitudinal direction along axis 101 such that relief channel 126 becomes more defined and begins to separate. Expansion portion 128 lengthens in the intermediate position such that the interior volume of chamber 130 is greater in the intermediate position than in the closed position.
  • FIGS. 4A and 4B show septum 102 in the fully open position, wherein expansion portion 128 has a third length L 3 greater than first and second lengths, L 1 and L 2 .
  • expansion portion 128 In the open position, expansion portion 128 is fully expanded and the interior volume of chamber 130 is greater in the open position than in the intermediate and closed positions.
  • relief channel 126 In the open position, relief channel 126 is fully open and exposes a plurality of apertures 138 defined within relief channel 126 .
  • Apertures 138 facilitate flow communication through outer wall 127 of expansion portion 128 between chamber 130 and the atmosphere surrounding expansion portion 128 .
  • apertures 138 facilitate fluid flow through expansion portion 128 between chamber 130 and receiving chamber 114 of housing 104 when expansion portion 128 is extended parallel to longitudinal axis 101 into receiving chamber 114 in the open position, as shown in FIGS. 5-7 .
  • FIG. 5 is a cross-section of system 100 with septum 102 in the closed position.
  • FIG. 6 is a cross-section view of system 100 with septum 102 in the intermediate position.
  • FIG. 7 is a cross-section view of system 100 with septum 102 in the open position.
  • septum 102 is configured to seal first end 108 of housing 104 .
  • septum 102 is mounted into receiving chamber 114 of housing 104 .
  • Septum 102 is contained within receiving chamber 114 by cap 106 , which is coupled to first end 108 of housing 104 .
  • cap 106 is coupled to outer surface 109 of housing first end 108 via a press-fit.
  • Expansion portion 128 extends a distance L 1 into receiving chamber 114 of housing 104 from head portion 124 of septum 102 when in the closed position (shown in FIG. 5 ). In the closed position, sealing portion 132 has a first diameter D 1 .
  • System 100 further includes a nosecone 103 housed within closed end 134 of chamber 130 of septum 102 .
  • nosecone 103 is formed of a metallic material, such as stainless steel, and is configured to prevent the piercing of septum 102 by needle 150 and to facilitate extension of expansion portion 128 during a transition from the closed position to the open position to establish a fluid flow channel as described in further detail below.
  • nosecone 103 is configured to align expansion portion 128 with longitudinal axis 101 .
  • System 100 further includes a biasing mechanism 105 to facilitate operation of system 100 , and, more specifically, septum 102 .
  • biasing mechanism 105 is a coil spring 107 positioned within receiving chamber 114 of housing 104 between fluid flow member 118 and a distal end of expansion portion 128 .
  • biasing mechanism 105 may be a spring that forms a portion of the resilient material comprising expansion portion 128 of septum 102 .
  • Biasing mechanism 105 is configured to facilitate closure of septum 102 when transitioning from the open position to the closed position as described in further detail below.
  • system 100 will be described with respect to needle 150 of a syringe 160 being inserted into opening 122 and a Luer device being connected to connector portion 117 of the second end 110 , where the Luer device is in communication with a fluid delivery system, such as an I.V. set.
  • a fluid delivery system such as an I.V. set.
  • the Luer device and I.V. set are omitted from the drawings for simplicity.
  • sealing portion 132 in the closed position is smaller than the diameter D 2 of needle, such that as needle 150 penetrates opening 136 , sealing portion 132 of septum 102 expands radially to accommodate the larger diameter needle 150 . Accordingly, a seal is created about needle 150 at sealing portion 132 of septum 102 that excludes exterior gases, liquids, or airborne matter from housing 104 .
  • nosecone 103 prevents the piercing or coring of septum 102 by needle tip 154 .
  • system 100 eliminates the possibility of particulates from septum 102 clogging needle 150 , contaminating the fluid transferred, or being introduced into the patient.
  • insertion of needle 150 facilitates deformation of septum 102 by extending expansion portion 128 into receiving chamber a distance L 2 , which is greater than distance L 1 .
  • expansion portion 128 transitions from the intermediate position to the open position.
  • the continued force of needle tip 154 upon nosecone 103 extends expansion portion 128 parallel to axis 101 into receiving chamber 114 a distance L 3 , which is greater than both distances L 1 and L 2 , in the open position.
  • Nosecone 103 also prevents obstruction of a needle side port 152 by an interior wall 142 of chamber 130 by acting as a spacer between side port 152 and interior wall 142 .
  • the extension of expansion portion 128 further compresses spring 107 such that spring 107 limits the extension of expansion portion 128 to prevent damaging septum 102 .
  • expansion portion 128 is fully extended in the open position such that relief channel 126 fully opens to expose a plurality of apertures 138 defined therein.
  • fluid flow member 118 , receiving chamber 114 , and septum 102 form a fluid flow channel 112 through housing 104 of system 100 to facilitate the transfer of fluid between syringe 160 and the Luer device. Accordingly, when septum 102 is in the open position, fluid may flow through the following structures (in the noted order), which as a whole make up fluid flow channel 112 : syringe 160 ; needle 150 ; chamber 130 (via needle side port 152 ); receiving chamber 114 (via apertures 138 ); fluid flow member 118 ; and the Luer device.
  • the plurality of apertures 138 and extension of expansion portion 128 facilitate fluid communication between syringe 160 and the inside of system housing 104 .
  • apertures 138 establish flow channel 112 between needle 150 and receiving chamber 114 .
  • Syringe 160 may then be activated to discharge fluid from syringe 160 through channel 112 into the Luer device or to withdraw fluid from the Luer device through channel 112 into syringe 160 .
  • needle 150 may be withdrawn from system 100 .
  • Spring 107 facilitates closure of septum 102 upon removal of needle 150 from septum 102 and maintains closure when septum 102 is not in use.
  • Expansion portion 128 is compressed along center axis 101 by spring 107 to close the plurality of apertures 138 and seal chamber 130 from receiving chamber 114 , thus providing a positive seal to prevent fluid communication and reduce contamination when expansion portion 128 is in the closed position.
  • the valve system is configured to prevent the piercing or coring of an expanding member, or septum, when a needle is inserted for fluid transfer through the system.
  • the system described herein includes a housing, the septum, and a cap to contain the septum within the housing.
  • the septum is formed from a resilient material and includes an expansion portion that extends into a receiving chamber of the housing from a closed position to an open position.
  • the expansion portion includes a relief channel that facilitates such expansion and includes a plurality of apertures formed in the relief channel that are exposed when the septum is fully extended. The plurality of apertures facilitates the establishment of a fluid flow channel through the system between the needle and a medical device coupled to the opposite end of the system housing.
  • the septum may be used in transferring a fluid between other types of devices.
  • a needle or cannula and a vial for use in a pumping system for filling or emptying a vial or tube, or for transferring fluid between a needle and an IV line.
  • a conventional needle such as a bevel-tipped needle may be used, or a blunt-tipped cannula including a side port.
  • removal of the needle from the septum returns the septum to its closed position. Closing may be aided by the presence of a biasing mechanism within the housing for returning and maintaining the septum in a closed position, and sealing the septum from contaminates when not in use.
  • the tip of the needle contacts a nosecone housed within a chamber within the expansion portion.
  • the force of the needle advancing into the septum causes the expansion of the expansion portion.
  • the nosecone not only facilitates extending the expansion portion to expose the apertures that create the fluid flow path, but also prevents the needle from coring the septum and introducing any particulates into the path. Preventing puncture or coring of the septum is particularly advantageous when the septum is used repeatedly.
  • Exemplary embodiments of a medical valve system with an expanding member are described above in detail. The system and its components are not limited to the specific embodiments described herein, but rather, components of the valve may be used independently and separately from other components described herein.
  • the expanding member may also be used in combination with other sealing systems and methods, and are not limited to practice with only the medical valve system as described herein.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A system for receiving a needle includes a valve that defines a fluid flow channel, and a housing having a first end, a second end, and a receiving portion. The system further includes a septum formed from a resilient material and mounted in the housing. The septum includes a head portion including a tapered opening, a sealing portion, and an expansion portion extending from the head portion opposite the tapered opening. The expansion portion includes a chamber having a closed end, at least one relief channel, and a plurality of apertures formed in the relief channel. The plurality of apertures facilitates fluid communication between the chamber and the receiving portion when the expansion portion is in an open position.

Description

    FIELD
  • The field relates generally to fluid valve systems, and more particularly to fluid valve systems having septa or a septum for receiving a needle.
  • BACKGROUND
  • Many conventional valve systems for sealing a container, especially those used in a medical or therapeutic setting, include a septum designed to be pierced by a needle or cannula of a syringe. Fluid may be transferred through the needle from the container to the syringe or vice versa.
  • Conventional needles often have holes at or near the tip of the needle. Holes through the septum formed by the needle may have an undesirable coring effect on the septum in which the needle undesirably removes a piece of the septum and creates particulates. These particulates may clog the needle or tube and obstruct the flow path of the fluid, or be released into the flow path and possibly into the patient. The particulates may further contaminate any fluid flowing through the flow path. Some septa have a pre-formed slit designed to receive the needle, but the needle may pierce the septum anywhere the tip makes contact, and may not necessarily be inserted through the slit area.
  • Moreover, repeated piercings of a septum by either a needle or a cannula may cause deterioration of the septum. This deterioration may lead to leakage and contamination. Many conventional valve systems and septa are designed to be used once, and repeated insertions of a needle or cannula not only introduce particulates into the flow path, but also facilitate leakage through the septum from stretching and overuse. It is important that the septum reseal with enough force that fluids do not leak therefrom and that airborne particulate matter, bacterial or viral matter do not enter therethrough. A more satisfactory system is needed.
  • This Background section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present disclosure, which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.
  • SUMMARY
  • In one aspect, a valve system for receiving a needle comprises a housing defining at least a portion of a fluid flow channel. The housing includes a first end, a second end, and a receiving portion. A septum is mounted in the housing for sealing the first end of the housing. The septum includes a longitudinal axis and is formed from a resilient material. The septum also includes a head portion including a tapered opening configured to receive the needle, a sealing portion configured to create a seal around the needle, and an expansion portion extending from the head portion opposite the tapered opening. The expansion portion includes a chamber having a closed end, at least one relief channel, and apertures formed in the relief channel. The apertures facilitate fluid communication between the chamber and the receiving portion when the expansion portion is extended parallel to the longitudinal axis into the receiving portion in an open position. The apertures are also configured to prevent flow communication when the expansion portion is in a closed position.
  • In another aspect, a septum comprises a head portion including a tapered opening configured to receive a needle about a longitudinal axis, a sealing portion configured to create a seal about a needle, and an expansion portion extending from the head portion opposite the tapered opening. The expansion portion includes a chamber having a closed end housed within the expansion portion, at least one relief channel, and a plurality of apertures formed in the relief channel. The apertures facilitate flow communication through the expansion portion when the expansion portion is extended parallel to the longitudinal axis in an open position. The apertures also prevent flow communication when the expansion portion is in a closed position.
  • Various refinements exist of the features noted in relation to the above-mentioned aspects. Further features may also be incorporated in the above-mentioned aspects as well. These refinements and additional features may exist individually or in any combination. For instance, various features discussed below in relation to any of the illustrated embodiments may be incorporated into any of the above-described aspects, alone or in any combination.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is an exploded perspective view of a valve system including a cap, a septum, and a housing of one embodiment;
  • FIG. 2A and FIG. 2B respectively show perspective and side views of the septum of FIG. 1 in a closed position;
  • FIG. 3A and FIG. 3B respectively show perspective and side views of the septum of FIG. 1 in an intermediate position;
  • FIG. 4A and FIG. 4B respectively show perspective and side views of the septum of FIG. 1 in an open position;
  • FIG. 5 is a cross-section view of the valve system of FIG. 1 with the septum in a closed position;
  • FIG. 6 is a cross-section view of the valve system of FIG. 1 with the septum in an intermediate position;
  • FIG. 7 is a cross-section view of the valve system of FIG. 1 with the septum in an open position;
  • DETAILED DESCRIPTION
  • Referring to FIG. 1, a system generally designated 100 is for use with a medical device of a fluid delivery system. However, system 100 may be used with other devices without departing from the scope of this disclosure. In this embodiment, system 100 is configured to prevent coring of an expanding member, such as a septum 102, when a needle (not shown in FIG. 1) is inserted therein, while maintaining a fluid flow channel (not shown in FIG. 1) therethrough. System 100 includes a cap 106 having a tapered opening 122 for receiving the needle, a housing 104 having a first end 108 for receiving cap 106, a receiving chamber 114 for receiving septum 102 that controls fluid flow through system 100, and a second end 110 to facilitate directing fluid between system 100 and a medical device. Housing 104, septum 102, and cap 106 are configured to be coaxially aligned along longitudinal centerline axis 101. In this embodiment, the fluid is in liquid form and passes through a centrally formed fluid flow channel as described in further detail below.
  • Many known medical devices are configured to facilitate the passage of fluids therethrough. The term “medical device” may be used to indicate such medical instruments as surgical tubing, syringes, IV sets, medical valve connectors, and other such devices. Medical devices may include, but are not limited to the above list. As described below, valve system 100 may be connected to a medical valve connector, such as a Luer connector. However, system 100 may be used to transfer a fluid between any two devices. For example, for transferring fluid between a needle or cannula and a vial, for use in a pumping system for filling or emptying a vial or tube, or for transferring fluid between a needle and an IV line. Furthermore, a conventional needle, such as a bevel-tipped needle may be used, or a blunt-tipped cannula including a side port. Alternatively, any needle or cannula may be used with system 100.
  • In this embodiment, septum 102 is mounted within housing 104 of system 100 for sealing housing first end 108 and is substantially secured within housing 104 by cap 106. Although system 100 is designed as a two-way fluid connector valve for flow of fluid between two medical devices, it is to be understood that the direction of fluid flow as well as the particular details, size and shape of system 100 and its components may vary, including providing for one-way fluid flow, if desired.
  • As shown in FIG. 1, cap 106 is configured to be coupled to first end 108 of housing 104. In this embodiment, cap 106 is coupled to housing 104 via a press-fit connection. Alternatively, cap 106 may be coupled to first end 108 of housing 104 by any connection means that allows for system 100 to function as described herein, such as threadably coupled, snap-fit, or permanently attached. Cap 106 includes a first end 119 and an opposing second end 121. Cap first end 119 includes conically-tapered opening 122 that narrows within cap 106 and is defined by an annular guiding surface 120. Guiding surface 120 extends into cap 106 such that opening 122 terminates between first end 119 and second end 121. Guiding surface 120 is configured to direct the needle through taped opening 122. Cap 106 is formed of a hard, durable material such that contact with the needle does not damage cap 106.
  • In this embodiment, septum 102 includes two adjacent elements or portions. In particular, septum 102 includes a head portion 124 and an expansion portion 128. A first end 123 of head portion 124 includes a second tapered opening 136 configured to receive a needle and expansion portion 128 includes a chamber (not shown in FIG. 1) defined therein and a relief channel 126. Expansion portion 128 extends from a head portion second end 125 opposite tapered opening 136. A sealing portion (not shown in FIG. 1) is defined within septum 102 between tapered opening 136 and the chamber. The sealing portion is configured to create a seal about the needle. The chamber is configured to receive the needle such that a pushing force by the needle facilitates to elongate expansion portion 128 along axis 101 as described in further detail below.
  • Housing 104 includes first end 108 and opposing second and 110. First end 108 is configured to accept cap 106 on an outer surface 109 and is further configured to receive septum 102 within receiving chamber 114 within first end 108. Second end 110 includes a fluid flow member 118 and a connector portion (not shown in FIG. 1) for connecting system 100 to a medical device, such as a Luer device. The connector portion may be threaded for ease of connection to the device. It is to be noted that any type of medical device may be connected to the connector portion of the second end 110. For ease of description, system 100 will be described with respect to the needle of a syringe being inserted into opening 122 and a Luer device being connected to the connector portion of the second end 110, where the Luer device is in communication with a fluid delivery system, such as an I.V. set. The Luer device and I.V. set are omitted from the drawings for brevity.
  • FIGS. 2A, 3A, and 4A illustrate a cross-sectional perspective view of septum 102 in the closed position, intermediate position, and open position, respectively. FIGS. 2B, 3B, and 4B show a perspective side view of septum 102 in the closed position, intermediate position, and open position, respectively. Septum 102 is made of a single piece of a substantially resilient material, such as rubber, latex, or silicone. Alternatively, septum 102 may be formed of any resilient material that enables system 100 to function as described herein. As described above, septum 102 includes head portion 124 and expansion portion 128. Head portion 124 includes first end 123 and opposing second end 125. Tapered opening 136 extends from head portion first end 123 toward head portion second end 125. Opening 136 is shaped substantially similarly to opening 122 such that guide surface 120 is received into opening 136 so as to direct the needle simultaneously through opening 122 of cap 106 and opening 136 of septum 102. A sealing portion 132 is defined within head portion 124 of septum 102. Sealing portion 132 extends from head portion second end 125 toward head portion first end 123. Tapered opening 136 and sealing portion 132 are in flow communication such that a channel is defined through head portion 124 between first and second ends 123 and 125.
  • In this embodiment, expansion portion 128 extends from head portion second end 125 opposite sealing portion 132 and opening 136. Expansion portion 128 includes a chamber 130 defined therein. Chamber 130 extends within expansion portion 128 between sealing portion 132 and a closed end 134 of chamber 130. Septum 102 is configured such that opening 136, sealing portion 132, and chamber 130 are co-axial about centerline 101 and form a single-ended tunnel between head portion first end 123 and chamber closed end 134.
  • Expansion portion 128 further includes a relief channel 126 formed in an outer wall 127 of expansion portion 128 and has a depth of approximately half the thickness of outer wall 127. Alternatively, relief channel 126 may be of any depth that facilitates septum 102 to function as described herein. In this embodiment, relief channel 126 is a continuously-spiraled channel defined between head portion second end 125 and a distal tip of expansion portion 128. Relief channel 126 terminates with a complete circular cut about the base of extension portion 128 at the union of expansion portion 128 and head portion second end 125. Alternatively, relief channel 126 may be a plurality or series of individual channels formed in outer wall 127.
  • FIGS. 2A and 2B show septum 102 in the relaxed, or closed, position, wherein expansion portion 128 is at rest and has a first length L1. In the closed position, relief channel 126 is closed and appears as a spiraled line about expansion portion 128. FIGS. 3A and 3B show septum 102 in an intermediate position, wherein expansion portion 128 is at least partially expanded. In the intermediate position, expansion portion 128 has a second length L2, which is greater than first length L1. Furthermore, extension portion 128 is extended in a longitudinal direction along axis 101 such that relief channel 126 becomes more defined and begins to separate. Expansion portion 128 lengthens in the intermediate position such that the interior volume of chamber 130 is greater in the intermediate position than in the closed position. FIGS. 4A and 4B show septum 102 in the fully open position, wherein expansion portion 128 has a third length L3 greater than first and second lengths, L1 and L2. In the open position, expansion portion 128 is fully expanded and the interior volume of chamber 130 is greater in the open position than in the intermediate and closed positions. In the open position, relief channel 126 is fully open and exposes a plurality of apertures 138 defined within relief channel 126. Apertures 138 facilitate flow communication through outer wall 127 of expansion portion 128 between chamber 130 and the atmosphere surrounding expansion portion 128. In this embodiment, apertures 138 facilitate fluid flow through expansion portion 128 between chamber 130 and receiving chamber 114 of housing 104 when expansion portion 128 is extended parallel to longitudinal axis 101 into receiving chamber 114 in the open position, as shown in FIGS. 5-7.
  • FIG. 5 is a cross-section of system 100 with septum 102 in the closed position. FIG. 6 is a cross-section view of system 100 with septum 102 in the intermediate position. FIG. 7 is a cross-section view of system 100 with septum 102 in the open position. In this embodiment, septum 102 is configured to seal first end 108 of housing 104. Specifically, septum 102 is mounted into receiving chamber 114 of housing 104. Septum 102 is contained within receiving chamber 114 by cap 106, which is coupled to first end 108 of housing 104. Specifically, cap 106 is coupled to outer surface 109 of housing first end 108 via a press-fit. Alternatively, cap 106 may be removably coupled to housing first end via interlocking threads or any other removable coupling means. System 100 is configured such that guide surface 120 of cap 106 is adjacent to tapered opening 136 such that opening 122 of cap 106, tapered opening 136, and sealing portion 132 of septum head portion 124 are coaxial along center axis 101 to simultaneously receive a needle 150 inserted therethrough.
  • Expansion portion 128 extends a distance L1 into receiving chamber 114 of housing 104 from head portion 124 of septum 102 when in the closed position (shown in FIG. 5). In the closed position, sealing portion 132 has a first diameter D1. System 100 further includes a nosecone 103 housed within closed end 134 of chamber 130 of septum 102. In this embodiment, nosecone 103 is formed of a metallic material, such as stainless steel, and is configured to prevent the piercing of septum 102 by needle 150 and to facilitate extension of expansion portion 128 during a transition from the closed position to the open position to establish a fluid flow channel as described in further detail below. Furthermore, nosecone 103 is configured to align expansion portion 128 with longitudinal axis 101.
  • System 100 further includes a biasing mechanism 105 to facilitate operation of system 100, and, more specifically, septum 102. In this embodiment, biasing mechanism 105 is a coil spring 107 positioned within receiving chamber 114 of housing 104 between fluid flow member 118 and a distal end of expansion portion 128. Alternatively, biasing mechanism 105 may be a spring that forms a portion of the resilient material comprising expansion portion 128 of septum 102. Biasing mechanism 105 is configured to facilitate closure of septum 102 when transitioning from the open position to the closed position as described in further detail below.
  • In this embodiment, housing second end 110 of system 100 includes fluid flow member 118 and connector portion 117 for coupling system 100 to a medical device (not shown). Fluid flow member 118 extends between housing second end 110 and receiving chamber 114 through connector portion 117, and is coaxial with receiving chamber 114, expansion portion 128, and openings 136 and 122 along center axis 101. Fluid flow member 118 is configured to facilitate the passage of fluid through system 100. An interior surface 115 of housing connector portion 117 is formed to include one or more threads or similar members 116 for connection of medical device, such as a Luer device. It is to be noted that any type of medical device may be connected to connector portion 117 of second end 110. For ease of description, system 100 will be described with respect to needle 150 of a syringe 160 being inserted into opening 122 and a Luer device being connected to connector portion 117 of the second end 110, where the Luer device is in communication with a fluid delivery system, such as an I.V. set. The Luer device and I.V. set are omitted from the drawings for simplicity.
  • In operation, the Luer device of this embodiment is threadably coupled to connector portion 117 of housing second end 110. FIG. 6 shows syringe 160 and needle 150, having a diameter D2, being inserted into system 100 with septum 102 in the intermediate position. Needle 150 is directed by guide surface 120 into system 100 through cap opening 122 and septum opening 136. Guide surface 120 is configured to direct needle 150 through openings 122 and 136 and also to protect from a tip 154 of needle 150 damaging head portion 124 of septum 102. In this embodiment, diameter D1 (shown in FIG. 5) of sealing portion 132 in the closed position is smaller than the diameter D2 of needle, such that as needle 150 penetrates opening 136, sealing portion 132 of septum 102 expands radially to accommodate the larger diameter needle 150. Accordingly, a seal is created about needle 150 at sealing portion 132 of septum 102 that excludes exterior gases, liquids, or airborne matter from housing 104.
  • As needle 150 is inserted through sealing portion, needle tip 154 advances through chamber 130 and impinges nosecone 103 at closed end 134 of chamber 130. In this embodiment, nosecone 103 prevents the piercing or coring of septum 102 by needle tip 154. By preventing such coring, system 100 eliminates the possibility of particulates from septum 102 clogging needle 150, contaminating the fluid transferred, or being introduced into the patient. During advancement of needle 150 into system 100, when septum 102 is in the intermediate position (shown in FIG. 6), insertion of needle 150 facilitates deformation of septum 102 by extending expansion portion 128 into receiving chamber a distance L2, which is greater than distance L1. Relief channel 126 facilitates such expansion by allowing expansion portion 128 to extend into receiving chamber 114 along center axis 101. The extension of expansion portion 128 compresses biasing mechanism 105 and coil spring 107 within receiving chamber 114. Spring 107 provides resistance to and limits the extension of expansion portion 128 within receiving chamber 114 to avoid damage to septum 102 when septum 102 is in the open position (shown in FIG. 7).
  • In this embodiment, as needle 150 is advanced farther into system 100, expansion portion 128 transitions from the intermediate position to the open position. The continued force of needle tip 154 upon nosecone 103 extends expansion portion 128 parallel to axis 101 into receiving chamber 114 a distance L3, which is greater than both distances L1 and L2, in the open position. Nosecone 103 also prevents obstruction of a needle side port 152 by an interior wall 142 of chamber 130 by acting as a spacer between side port 152 and interior wall 142. The extension of expansion portion 128 further compresses spring 107 such that spring 107 limits the extension of expansion portion 128 to prevent damaging septum 102. In this embodiment, expansion portion 128 is fully extended in the open position such that relief channel 126 fully opens to expose a plurality of apertures 138 defined therein.
  • In the open position of FIG. 7, fluid flow member 118, receiving chamber 114, and septum 102 form a fluid flow channel 112 through housing 104 of system 100 to facilitate the transfer of fluid between syringe 160 and the Luer device. Accordingly, when septum 102 is in the open position, fluid may flow through the following structures (in the noted order), which as a whole make up fluid flow channel 112: syringe 160; needle 150; chamber 130 (via needle side port 152); receiving chamber 114 (via apertures 138); fluid flow member 118; and the Luer device.
  • The plurality of apertures 138 and extension of expansion portion 128 facilitate fluid communication between syringe 160 and the inside of system housing 104. Specifically, apertures 138 establish flow channel 112 between needle 150 and receiving chamber 114. Syringe 160 may then be activated to discharge fluid from syringe 160 through channel 112 into the Luer device or to withdraw fluid from the Luer device through channel 112 into syringe 160. Once operation of syringe 160 is complete, needle 150 may be withdrawn from system 100. Spring 107 facilitates closure of septum 102 upon removal of needle 150 from septum 102 and maintains closure when septum 102 is not in use. Expansion portion 128 is compressed along center axis 101 by spring 107 to close the plurality of apertures 138 and seal chamber 130 from receiving chamber 114, thus providing a positive seal to prevent fluid communication and reduce contamination when expansion portion 128 is in the closed position.
  • The valve system is configured to prevent the piercing or coring of an expanding member, or septum, when a needle is inserted for fluid transfer through the system. The system described herein includes a housing, the septum, and a cap to contain the septum within the housing. The septum is formed from a resilient material and includes an expansion portion that extends into a receiving chamber of the housing from a closed position to an open position. The expansion portion includes a relief channel that facilitates such expansion and includes a plurality of apertures formed in the relief channel that are exposed when the septum is fully extended. The plurality of apertures facilitates the establishment of a fluid flow channel through the system between the needle and a medical device coupled to the opposite end of the system housing. Although the system is described as being connected to a Luer connector, the septum may be used in transferring a fluid between other types of devices. For example, for transferring fluid between a needle or cannula and a vial, for use in a pumping system for filling or emptying a vial or tube, or for transferring fluid between a needle and an IV line. A conventional needle, such as a bevel-tipped needle may be used, or a blunt-tipped cannula including a side port. After the transfer of desired fluid, removal of the needle from the septum returns the septum to its closed position. Closing may be aided by the presence of a biasing mechanism within the housing for returning and maintaining the septum in a closed position, and sealing the septum from contaminates when not in use.
  • To facilitate expansion of the septum from the closed position to the open position, the tip of the needle contacts a nosecone housed within a chamber within the expansion portion. The force of the needle advancing into the septum causes the expansion of the expansion portion. The nosecone not only facilitates extending the expansion portion to expose the apertures that create the fluid flow path, but also prevents the needle from coring the septum and introducing any particulates into the path. Preventing puncture or coring of the septum is particularly advantageous when the septum is used repeatedly. Exemplary embodiments of a medical valve system with an expanding member are described above in detail. The system and its components are not limited to the specific embodiments described herein, but rather, components of the valve may be used independently and separately from other components described herein. For example, the expanding member may also be used in combination with other sealing systems and methods, and are not limited to practice with only the medical valve system as described herein.
  • When introducing elements of the present disclosure or the embodiment(s) thereof, the articles “a”, “an”, “the” and “said” are intended to mean that there are one or more of the elements. The terms “comprising,” “including,” “containing” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. The use of terms indicating a particular orientation (e.g., “top”, “bottom”, “side”, etc.) is for convenience of description and does not require any particular orientation of the item described.
  • As various changes could be made in the above constructions and methods without departing from the scope of the disclosure, it is intended that all matter contained in the above description and shown in the accompanying drawing(s) shall be interpreted as illustrative and not in a limiting sense.

Claims (26)

What is claimed is:
1. A valve system for receiving a needle comprising:
a housing defining a fluid flow channel therethrough, the housing having a first end, a second end, and a receiving portion;
a septum having a longitudinal axis and including a resilient material, the septum mounted in the housing for sealing the first end of the housing, the septum comprising:
a head portion including a tapered opening for receiving the needle;
a sealing portion for creating a seal around the needle;
an expansion portion extending from the head portion opposite the tapered opening, the expansion portion including a chamber having a closed end, the expansion portion further including a relief channel and apertures formed in the relief channel such that the apertures facilitate fluid communication between the chamber and the receiving portion when the expansion portion is extended parallel to the longitudinal axis into the receiving portion in an open position and the apertures are configured to prevent fluid communication when the expansion portion is in a closed position.
2. The valve system of claim 1, wherein movement of the expansion portion between the open and closed positions is caused by advancing the needle through the sealing portion and into the chamber.
3. The valve system in accordance with claim 1, further comprising a housing cap on the first end of the housing.
4. The valve system in accordance with claim 3, wherein the housing cap includes a conically shaped opening for receiving the needle through the housing cap and into the head portion of the septum.
5. The valve system in accordance with claim 1, further comprising a spring for biasing the septum in the closed position when the septum is not in use and for returning the septum to the closed position from the open position upon removal of the needle from the septum.
6. The valve system in accordance with claim 5, wherein the spring forms a portion of the resilient material of the septum.
7. The valve system in accordance with claim 5, wherein the spring is a coil spring.
8. The valve system in accordance with claim 1 further comprising a nosecone within the closed end of the chamber, the nosecone adapted to prevent the needle from piercing the closed end and to align the expansion portion with the longitudinal axis.
9. The valve system in accordance with claim 8, wherein the nosecone includes a metallic material.
10. The valve system in accordance with claim 1, wherein the resilient material includes at least one of rubber, latex, or silicone.
11. The valve system in accordance with claim 1, wherein the relief channel is a spiral channel extending about the length of the expansion portion.
12. The valve system in accordance with claim 1, wherein the relief channel includes a plurality of individual channels formed in an outer wall of the expansion portion.
13. The valve system in accordance with claim 1, wherein the relief channel includes a full circular cut about a base of the extension portion.
14. The valve system in accordance with claim 1, wherein the housing includes a fluid flow member that extends between the second end and the receiving portion, the fluid flow member is configured to facilitate the passage of fluid through the valve.
15. The valve system in accordance with claim 1, wherein the housing includes a threaded portion at the second end, the threaded portion is configured to couple the valve to a medical device.
16. The valve system in accordance with claim 1, wherein the receiving portion is configured to receive the expansion portion when the expansion portion is in the open position.
17. The valve system in accordance with claim 1, wherein the sealing portion has a diameter smaller than a diameter of the needle such that a seal is formed about the needle.
18. A septum for receiving a needle comprising:
a head portion including a tapered opening having a longitudinal axis and adapted to receive the needle;
a sealing portion adapted to create a seal about the needle;
an expansion portion extending from the head portion opposite the tapered opening, the expansion portion including a chamber having a closed end housed within the expansion portion, the expansion portion further including at least one relief channel and a plurality of apertures formed in the relief channel such that the apertures facilitate flow communication through the expansion portion when the expansion portion is extended parallel to the longitudinal axis in an open position and the plurality of apertures are configured to prevent fluid communication when the expansion portion is in a closed position.
19. The septum in accordance with claim 18, wherein movement of the expansion portion between the first and second positions is facilitated by advancing the needle through the sealing portion and into the chamber.
20. The septum in accordance with claim 18, wherein the relief channel is a spiral channel about the length of expansion portion.
21. The septum in accordance with claim 18, wherein the relief channel includes a plurality of individual channels formed in an outer wall of the expansion portion.
22. The septum in accordance with claim 18, wherein the relief channel includes a full circular cut about a base of the expansion portion.
23. The septum in accordance with claim 18, wherein the sealing portion has a diameter smaller than a diameter of the needle such that a seal is formed about the needle.
24. The septum in accordance with claim 18, wherein the chamber is configured to house a metallic nosecone at the closed end, the metallic nosecone is configured to prevent the needle from piercing the closed end and to align the expansion portion with the longitudinal axis.
25. The septum in accordance with claim 18, wherein the septum is comprised of a resilient material.
26. The septum in accordance with claim 25, wherein the resilient material is one of rubber, latex, or silicone.
US13/802,935 2013-03-14 2013-03-14 Coring-free valve system Abandoned US20140263322A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US13/802,935 US20140263322A1 (en) 2013-03-14 2013-03-14 Coring-free valve system
PCT/US2014/020582 WO2014158859A1 (en) 2013-03-14 2014-03-05 Coring-free valve system

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US13/802,935 US20140263322A1 (en) 2013-03-14 2013-03-14 Coring-free valve system

Publications (1)

Publication Number Publication Date
US20140263322A1 true US20140263322A1 (en) 2014-09-18

Family

ID=50346148

Family Applications (1)

Application Number Title Priority Date Filing Date
US13/802,935 Abandoned US20140263322A1 (en) 2013-03-14 2013-03-14 Coring-free valve system

Country Status (2)

Country Link
US (1) US20140263322A1 (en)
WO (1) WO2014158859A1 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018507755A (en) * 2015-03-16 2018-03-22 エクアシールド メディカル リミテッド Diaphragm holder for syringe connector
CN111819437A (en) * 2017-12-20 2020-10-23 色谱研究供应股份有限公司 Diaphragm with chamber
US11951273B2 (en) 2020-03-06 2024-04-09 B. Braun Melsungen Ag Coupling system for a closed fluid transfer system

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0143518A1 (en) * 1983-09-02 1985-06-05 Minntech Corporation Dispenser for peritoneal cavity
US5064416A (en) * 1988-05-26 1991-11-12 Newgard Kent W Self-occluding intravascular cannula assembly
US5360413A (en) * 1991-12-06 1994-11-01 Filtertek, Inc. Needleless access device
US5380306A (en) * 1991-11-25 1995-01-10 Vygon Unitary composite connector for a liquid circuit, in particular for medical applications
US5573516A (en) * 1995-09-18 1996-11-12 Medical Connexions, Inc. Needleless connector
US5578059A (en) * 1993-11-30 1996-11-26 Medex, Inc. Anti-reflux valve with environmental barrier
CA2275218A1 (en) * 1996-12-16 1998-06-25 Icu Medical, Inc. Positive flow valve
US6595964B2 (en) * 2000-12-22 2003-07-22 Baxter International Inc. Luer activated thread coupler
US20040097961A1 (en) * 2002-11-19 2004-05-20 Vascular Control System Tenaculum for use with occlusion devices
US20040195538A1 (en) * 2003-04-03 2004-10-07 Raines Kenneth C Injection port valve
US20080103482A1 (en) * 2006-10-25 2008-05-01 Icu Medical, Inc. Medical connector

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5242393A (en) * 1992-06-18 1993-09-07 Becton, Dickinson And Company Valved blunt cannula injection site
AU1332795A (en) * 1993-11-30 1995-06-19 Medex, Inc. Plastic needleless valve housing for standard male luer locks
US7520489B2 (en) * 2003-06-17 2009-04-21 Filtertek Inc. Fluid handling device and method of making same
US7981090B2 (en) * 2006-10-18 2011-07-19 Baxter International Inc. Luer activated device

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0143518A1 (en) * 1983-09-02 1985-06-05 Minntech Corporation Dispenser for peritoneal cavity
US5064416A (en) * 1988-05-26 1991-11-12 Newgard Kent W Self-occluding intravascular cannula assembly
US5380306A (en) * 1991-11-25 1995-01-10 Vygon Unitary composite connector for a liquid circuit, in particular for medical applications
US5360413A (en) * 1991-12-06 1994-11-01 Filtertek, Inc. Needleless access device
US5578059A (en) * 1993-11-30 1996-11-26 Medex, Inc. Anti-reflux valve with environmental barrier
US5573516A (en) * 1995-09-18 1996-11-12 Medical Connexions, Inc. Needleless connector
CA2275218A1 (en) * 1996-12-16 1998-06-25 Icu Medical, Inc. Positive flow valve
US6595964B2 (en) * 2000-12-22 2003-07-22 Baxter International Inc. Luer activated thread coupler
US20040097961A1 (en) * 2002-11-19 2004-05-20 Vascular Control System Tenaculum for use with occlusion devices
US20040195538A1 (en) * 2003-04-03 2004-10-07 Raines Kenneth C Injection port valve
US20080103482A1 (en) * 2006-10-25 2008-05-01 Icu Medical, Inc. Medical connector

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018507755A (en) * 2015-03-16 2018-03-22 エクアシールド メディカル リミテッド Diaphragm holder for syringe connector
US10765601B2 (en) 2015-03-16 2020-09-08 Equashield Medical Ltd. Septum holders for use in syringe connectors
US11690785B2 (en) 2015-03-16 2023-07-04 Equashield Medical Ltd. Septum holders for use in syringe connectors
US11759394B2 (en) 2015-03-16 2023-09-19 Equashield Medical Ltd. Septum holders for use in syringe connectors
CN111819437A (en) * 2017-12-20 2020-10-23 色谱研究供应股份有限公司 Diaphragm with chamber
US11951273B2 (en) 2020-03-06 2024-04-09 B. Braun Melsungen Ag Coupling system for a closed fluid transfer system

Also Published As

Publication number Publication date
WO2014158859A1 (en) 2014-10-02

Similar Documents

Publication Publication Date Title
US5868721A (en) Injection device having anti-coring needle
EP3622890B1 (en) Blood sample optimization system and blood contaminant sequestration device
US3659587A (en) Valved connector arrangement
US9216138B2 (en) Self-venting cannula assembly
EP1827568B1 (en) Self-sealing male luer connector with multiple seals
EP1825840A1 (en) Minute quantity medicine administration set
US11724086B2 (en) Medical devices and methods for fluid transfer
JP2014506494A (en) Connection device for connecting first reservoir to second reservoir
WO1997014461A9 (en) Anti-coring needle
NO321794B1 (en) Medical valve with positive flow characteristic, and method of effecting positive fluid flow
US20140263322A1 (en) Coring-free valve system
EP3192585B1 (en) Mating structure of liquid extraction piece and test tube assembly
JP2023501267A (en) Blood collection system with user-adjusted pressure management and related methods
US20200305780A1 (en) Non-venting bodily fluid sample optimization device and system
KR20170054416A (en) Adapter for semi-solid nutritional supplement
KR20220100935A (en) Blood collection system with automatic pressure management and related methods
US20150352013A1 (en) Needle kit
US20120109101A1 (en) System for access into bodily cavity
US20160296740A1 (en) Non-luer compatible administration port
US11420025B2 (en) Catheter assembly having a side port valve
US10379010B2 (en) Segment sampler
CN109952085B (en) Bidirectional valveless sampling port matched with gas sampling bag for use
EP3381420B1 (en) Piercing needle-equipped cannula
JP4044890B2 (en) Medical sliding on-off valve
US20240050697A1 (en) Cannulation systems and methods

Legal Events

Date Code Title Description
AS Assignment

Owner name: MALLINCKRODT LLC, MISSOURI

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:GHODBANE, SALAH;DAWSON, GARY E.;MOOS, KIMBERLY A.;SIGNING DATES FROM 20131203 TO 20140131;REEL/FRAME:032431/0019

AS Assignment

Owner name: DEUTSCHE BANK AG NEW YORK BRANCH, NEW YORK

Free format text: SECURITY INTEREST;ASSIGNORS:MALLINCKRODT INTERNATIONAL FINANCE S.A.;MALLINCKRODT CB LLC;MALLINCKRODT FINANCE GMBH;AND OTHERS;REEL/FRAME:032480/0001

Effective date: 20140319

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION

AS Assignment

Owner name: INO THERAPEUTICS LLC, MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: IKARIA THERAPEUTICS LLC, NEW JERSEY

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: THERAKOS, INC., MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: ST SHARED SERVICES LLC, MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: INFACARE PHARMACEUTICAL CORPORATION, MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING D.A.C.), IRELAND

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED, IRELAND

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: VTESSE LLC (F/K/A VTESSE INC.), MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: SUCAMPO PHARMA AMERICAS LLC, MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: STRATATECH CORPORATION, WISCONSIN

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: SPECGX LLC, MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.), MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED), IRELAND

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED), IRELAND

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MEH, INC., MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: IMC EXPLORATION COMPANY, MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT US HOLDINGS LLC, MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT VETERINARY, INC., MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT BRAND PHARMACEUTICALS LLC (F/K/A MALLINCKRODT BRAND PHARMACEUTICALS, INC.), MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: LIEBEL-FLARSHEIM COMPANY LLC, MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: LAFAYETTE PHARMACEUTICALS LLC, MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT LLC, MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT ENTERPRISES LLC, MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT ENTERPRISES HOLDINGS LLC (F/K/A MALLINCKRODT ENTERPRISES HOLDINGS, INC.), MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: CNS THERAPEUTICS, INC., MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: LUDLOW LLC (F/K/A LUDLOW CORPORATION), MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MNK 2011 LLC (F/K/A MALLINCKRODT INC.), MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT US POOL LLC, MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT CARRIBEAN, INC., MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT US HOLDINGS LLC (F/K/A MALLINCKRODT US HOLDINGS INC.), MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT FINANCE GMBH, SWITZERLAND

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT CB LLC, MISSOURI

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114

Owner name: MALLINCKRODT INTERNATIONAL FINANCE S.A., LUXEMBOURG

Free format text: RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001;ASSIGNOR:DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT;REEL/FRAME:065609/0322

Effective date: 20231114